Teva Pharmaceuticals B Pharma/M Pharma job opening 2023, Regulatory affairs job opening 2023, Pharmacy job opening 2023. Intrested and eligible candidates may check out all the details on the same below:
Job Title: Regulatory Affairs Associate II – 1435
Location: Bangalore, India, 560064
Company: Teva Pharmaceuticals
Job Id: 49832
Qualifications: B. Pharm/M. Pharm/ Master of Life Sciences.
Experience: Total years of experience required for the role: 4-7 years (preferred – Regulatory Publishing experience in EU and US market)
Knowledge and skills:
Strategic thinking, strong interpersonal skills including troubleshooting of errors while publishing, strong analytical skills, strong multi-cultural skills, high energy level
Command over spoken and written English
Sensitivity to the cultural diversity of a global organization
The opportunity
Regulatory Affairs associate II – RA publishing will participate in the publishing of different regulatory activities. The focus will be to ensure 100% quality and timeline of the submission. This role will be the primary interface with the Regulatory Affairs Associate
How you’ll spend your day
- Publish and dispatch major and complex routine/lifecycle management eCTD submission projects for EU, US and Canada.
- Exposure in handling initial submissions publishing and transmitting quality submissions to agency.
- Perform document level publishing activities, troubleshoot document issues and perform quality control checks for submission ready documents as per the agency guidance.
- Collaborate with scientific personnel for planning, preparation, publishing and quality control checks of submissions for self as well as peers.
- Hands on expertise in EU submissions from pre-approval to post approval activities like initial, variations, PSUR etc.
- Basic understanding of regulatory strategy
- Participate in Global Regulatory Affairs project teams
- Maintain working knowledge of internal and external publishing standards.
- Knowledge of ICH and eCTD related specification/guidelines governing regulatory submissions (eCTD, NeeS, paper)
- Must be aware of Technical systems like Global Insight, Veeva Vault, ISI Toolbox, Adobe Acrobat, Lorenz/EURS validator
- Sees opportunities for creative problem solving while staying within the parameters of good practice. Generates unique but workable and useful solutions to difficult problems.
- Proactively participate in upcoming projects and provide inputs wherever necessary
Plan the trainings/knowledge sharing sessions which helps junior team members to understand the process - Act as buddy for new joiners
- Risk/benefit analysis skills
Apply Online
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